Skip to navigation Skip to content

News

Share

FDA Approves Lemtrada™ (alemtuzumab) for Relapsing MS - UPDATE

November 14, 2014

UPDATED December 18, 2014

The U.S. Food and Drug Administration has approved Lemtrada™ (alemtuzumab, Genzyme, a Sanofi Company) as a disease-modifying therapy for people with relapsing forms of MS. Lemtrada is given as intravenous infusions – for 5 consecutive days initially and for 3 consecutive days one year later. Because of its safety profile, the prescribing information indicates that use of Lemtrada should generally be reserved for people who have had an inadequate response to two or more MS therapies.

“The approval of Lemtrada provides an important and immunologically powerful new therapeutic option for people with relapsing MS,” said Bruce A. Cohen, MD, Professor, Davee Department of Neurology and Clinical Neurosciences at Northwestern University’s Feinberg School of Medicine, and Chair of the National MS Society’s National Medical Advisory Committee. “Its long-lasting effects may profoundly influence the course of relapsing MS, but will require careful and sustained monitoring for side effects which people receiving the medicine must follow. Individuals with MS who are considering treatment with this medicine should thoroughly educate themselves on its potential benefits and risks,” he added.

“The FDA approval of Lemtrada is a significant milestone for people living with relapsing MS in the United States,” said Dr. Timothy Coetzee, Chief Advocacy, Services and Research Officer at the National MS Society. “We are pleased that that the voices of the MS community have been recognized and that people with relapsing MS will now have access to a new, needed treatment option.

About Lemtrada: MS involves immune system attacks against brain and spinal cord tissues. Lemtrada is a humanized monoclonal antibody directed at CD52 (a protein on the surface of immune cells) and it causes depletion of lymphocytes (white blood cells). It was originally approved, at a significantly higher dose, for the treatment of B-cell chronic lymphocytic leukemia. Its ability to target immune cells led investigators to test its potential as a treatment for relapsing MS.

Lemtrada is given by intravenous infusion – for 5 consecutive days initially and for 3 consecutive days one year later. The prescribing information includes a boxed warning about the potential for serious or life-threatening autoimmune disorders, infusion reactions and malignancies. Lemtrada will only be available from certified prescribers, and patients will be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program to ensure that ongoing periodic monitoring will be maintained to detect potential problems. 

Potential benefits: The FDA approved Lemtrada based on the results of two large, phase III clinical trials that confirmed its ability to significantly reduce relapse rates over two years over standard subcutaneous dosing of Rebif® (interferon beta-1a, EMD Serono Inc. and Pfizer). One of the studies also suggested that Lemtrada may significantly reduce worsening of disability. Alasdair Coles, FRCP (University of Cambridge) and Jeffrey Cohen, MD (Cleveland Clinic) and colleagues published the complete results of CARE-MS I and CARE-MS II in The Lancet (2012;380:2819, read more here).

  • In the CARE-MS I study, data were evaluated for 563 people with early, active relapsing-remitting MS, who had never received disease-modifying therapy to treat their MS and were randomly assigned to receive Lemtrada or Rebif. After two years the relapse rate for those on Lemtrada was reduced by 55% compared to those on Rebif. Also after two years, 8% of those on Lemtrada experienced an increase (worsening) in their EDSS score (a standard scale of physical disability) compared to 11 % on Rebif – a difference that was not statistically significant. After two years 78% of those on Lemtrada remained relapse-free, which was significantly more than the 59% who remained relapse-free on Rebif.
  • The CARE-MS II study was a two-year trial comparing Lemtrada to the standard subcutaneous dosing of Rebif. Data were evaluated for 628 people with relapsing-remitting MS who had already been treated with another MS therapy but had experienced at least one relapse on that previous therapy. After two years, the annual relapse rate for those on Lemtrada was 0.26 compared to 0.52 for those on Rebif, representing a 49% lower risk of relapses. In addition, on average fewer people on Lemtrada had an increase (worsening) in their EDSS score compared to those on Rebif (13% for Lemtrada vs. 21% for Rebif) – a 42% difference that was statistically significant. After two years, 65% of those on Lemtrada remained relapse-free compared to 47% on Rebif, which was also statistically significantly.

Potential risks: Prescribing information for Lemtrada includes a boxed warning about the potential for serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia (a rare bleeding condition) and anti-glomerular basement membrane disease (which impacts the kidneys). It also warns about serious and life-threatening infusion reactions (reactions occurring during or more than 24 hours after the administration of the medication), increased risk of malignancies (including thyroid cancer, melanoma, and blood cancers). Autoimmune thyroid disorders occurred in 34% of people treated with Lemtrada in clinical studies.

The most common adverse reactions noted in people who have taken Lemtrada include rash, headache, fever, nasal congestion, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, hives, itching, thyroid gland disorders, fungal infection, pain in joints, extremities and back, diarrhea, sinusitis, sore mouth and throat, tingling, dizziness, abdominal pain, flushing and vomiting.

FDA screening and monitoring recommendations: The FDA recommends that before starting treatment:

  • it should be determined whether the individual has been vaccinated for varicella zoster virus, and if not, tested for antibodies and vaccinated if needed 6 weeks prior to beginning treatment with Lemtrada;
  • thyroid function tests such as thyroid stimulating hormone level should be obtained before treatment and every 3 months until 48 months after the last infusion;
  • full blood count with differential should be obtained prior to treatment and monthly thereafter until 48 months after the last infusion;
  • serum creatinine levels should be obtained prior to treatment and monthly thereafter until 48 months after the last infusion;
  • urinalysis  with urine cell counts be obtained prior to treatment and monthly thereafter until 48 months after the last infusion;
  • skin exam should occur at start of treatment and yearly thereafter to monitor for melanoma;
  • people with active infections should consider delaying treatment until the infection is controlled.
  • People should not have live-virus vaccines after a course of Lemtrada.

Monitoring information and recommendations will be provided to individuals enrolled in the Lemtrada REMS program.

Before starting treatment with Lemtrada, women should talk to their health care providers if they are pregnant or planning to become pregnant.

Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Selecting an MS therapy should be done by people with MS in collaboration with their MS doctors, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.

For more information about support services Contact Genzyme at 1- 855-MSOne2One.

Download the prescribing information (.pdf)

Read more about disease-modifying therapies and other treatments for MS and MS symptoms

Lemtrada is a trademark of Genzyme, a Sanofi Company.

FAQ About FDA’s Approval of Alemtuzumab – Brand name Lemtrada™ – for Relapsing MS

Q. What is Lemtrada?
A. Lemtrada is a humanized monoclonal antibody directed at CD52 (a protein on the surface of immune cells). It depletes the number of lymphocytes (types of white blood cells). It was originally approved at a significantly higher dose for the treatment of B-cell chronic lymphocytic leukemia. Its ability to target immune cells led investigators to test its potential as a treatment for relapsing-remitting MS.

Q. What types of MS is Lemtrada approved to treat?
A. The FDA has approved Lemtrada for the treatment of people with relapsing forms of MS. In other words, people who experience periodic MS attacks, such as those who have relapsing-remitting MS or secondary-progressive MS with relapses. Because of its safety profile, it is generally be reserved for people who have had an inadequate response to two or more MS therapies.

Q. How is Lemtrada taken?
A. Lemtrada is given by intravenous infusions – for 5 consecutive days initially and for 3 consecutive days one year later.

Q. Will my regular doctor be able to prescribe Lemtrada for me?
A. Possibly. All infusion centers and prescribers will be required to be certified so that they are educated about the potential risks of Lemtrada and the importance of monitoring for early signs of possible safety issues. If your regular doctor undergoes the training to become certified to prescribe Lemtrada, then he or she will be able to prescribe Lemtrada.

Q. How will I get Lemtrada if my regular doctor is not certified to prescribe it?
A. If your regular doctor is not certified to prescribe Lemtrada, individuals may contact Genzyme for information about qualified healthcare facilities.

Q. Is Lemtrada appropriate as a treatment for anyone who has relapsing MS?
A. No. Because of its safety profile, the use of Lemtrada should generally be reserved for people who have had an inadequate response to two or more MS therapies. Individuals will be enrolled in a Risk Evaluation and Mitigation Strategy (REMS) program to educate them about important health monitoring required by those who take this therapy. Lemtrada can cause serious adverse health problems, and its use requires frequent and long-term monitoring, including monthly blood tests for a minimum of five years (four years of monthly and quarterly monitoring after a person’s last infusion). Because Lemtrada has long-term implications for an individual’s lifestyle and the potential for health risks, making the decision to commit to following the safety monitoring requires careful consideration. 

Q. When will Lemtrada be available by prescription?
A. A process is in place to train and certify prescribers and treatment centers, and Lemtrada is expected to be available in December 2014. Individuals may contact Genzyme for information about certified prescribers and healthcare facilities.

Q. How effective is Lemtrada?
A. In two phase III clinical trials, Lemtrada significantly reduced relapse rates over two years by 49.4 to 55% over standard subcutaneous dosing of Rebif (interferon beta-1a, EMD Serono Inc. and Pfizer). In both studies, a higher proportion of people on Lemtrada were relapse-free than those on Rebif. One of the studies also suggested that Lemtrada significantly reduced worsening of disability by 42% over Rebif.

Q. What are the potential side effects of Lemtrada?
A. Prescribing information for Lemtrada includes a boxed warning about the potential for serious, sometimes fatal, autoimmune conditions such as immune thrombocytopenia (a rare bleeding condition) and anti-glomerular basement membrane disease (which impacts the kidneys). It also warns about serious and life-threatening infusion reactions, increased risk of malignancies (including thyroid cancer, melanoma, and blood cancers). Autoimmune thyroid disorders occurred in 34% of people treated with Lemtrada in clinical studies.

The most common adverse reactions noted in people who have taken Lemtrada include rash, headache, fever, nasal congestion, nausea, urinary tract infection, fatigue, insomnia, upper respiratory tract infection, herpes viral infection, hives, itching, thyroid gland disorders, fungal infection, pain in joints, extremities and back, diarrhea, sinusitis, sore mouth and throat, tingling, dizziness, abdominal pain, flushing and vomiting.

Q. Why should a person with MS consider taking a disease-modifying therapy?
A. Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Studies comparing people in clinical trials who started therapy earlier than those on inactive placebo suggest that early treatment offered important benefits against the accumulation of disability, which were generally not experienced to the same degree by those who started treatment later.

Selecting an MS therapy should be done by people with MS in collaboration with their MS doctors, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.

Q. Should I switch from my current therapy to Lemtrada?
A. The decision about whether to take Lemtrada should be made in collaboration with your MS doctor, taking into account a variety of factors including the effectiveness of any therapy you are currently using, the potential risks and benefits, as well as costs and lifestyle factors. Important questions to be considered and discussed with your doctor in terms of Lemtrada include:
• How am I doing on my current therapy?
• What is my tolerance for the risk of known side effects?
• Am I willing to pledge to long-term, monthly blood draws and other tests that will be needed to identify potential safety issues for four years after my last infusion?
• What is my tolerance for the risk of adverse consequences that might emerge later?
• How will my medication choice affect my ability or plans to become pregnant?
• What are the comparative costs of my current therapy versus Lemtrada?

Q. How does the effectiveness of Lemtrada compare to other available therapies?
A. Lemtrada significantly reduced relapse rates over two years over standard subcutaneous dosing of Rebif. Lemtrada has not been compared to other disease-modifying therapies.

Q. How long would a person take Lemtrada?
A. Prescribing information notes that the recommended dosing of Lemtrada is two treatment courses one year apart.

Q. Are there any risk factors or medical conditions that would make it inappropriate for an individual to take Lemtrada?
A. Lemtrada is not appropriate for someone with infection with HIV (human immunodeficiency virus). Lemtrada is rated as a Pregnancy Category C. There have been no adequate studies in pregnant women, but based on animal studies, Lemtrada may cause harm to the fetus.

Q. Will a person taking Lemtrada have to get any special medical tests or monitoring?
A. Yes. The FDA recommends that before starting treatment:
• it should be determine whether the individual has been vaccinated for varicella zoster virus, and if not, tested for antibodies and vaccinated if appropriate 6 weeks prior to beginning treatment with Lemtrada;
• thyroid function tests such as thyroid stimulating hormone level should be obtained before treatment and every 3 months until 48 months after the last infusion;
• full blood count with differential should be obtained prior to treatment and monthly thereafter until 48 months after the last infusion;
• serum creatinine levels should be obtained prior to treatment and monthly thereafter until 48 months after the last infusion;
• urinalysis  with urine cell counts be obtained prior to treatment and monthly thereafter until 48 months after the last infusion;
• skin exam should occur at start of treatment and yearly thereafter to monitor for melanoma;
• people with active infections should consider delaying treatment until the infection is controlled.
• People should not have live-virus vaccines after a course of Lemtrada.

Monitoring information and recommendations will be provided to individuals enrolled in the Lemtrada Risk Evaluation and Mitigation Strategy program.

Q. What should I know about the infusion process?
A. It is recommended that individuals receive corticosteroids prior to the Lemtrada infusion and for the first 3 days of each treatment course. Patients should be given antiviral therapy to prevent herpes infection starting on the first day of Lemtrada infusion and for a minimum of two months after dosing or until blood lymphocyte count reaches a specified level. Each Lemtrada infusion is given over 4 hours, after which the person is monitored for two additional hours for any signs of adverse reactions.

Q. What will Lemtrada cost?
A. The actual cost to an individual who has MS will depend on the provisions of his or her insurance coverage and the degree to which that individual will be eligible for programs designed to assist with out-of-pocket costs.

Q. Will my health insurance cover Lemtrada?
A. Coverage will depend on individual insurance plans.

Q. Is there a generic form of Lemtrada?
A. No. 

Q. Where can I get information about the patient support that Genzyme plans to provide?
A. For more information about support services, contact Genzyme at 1- 855-MSOne2One.

Q. Are there other disease-modifying therapies available or in development for MS?
A. Yes, there are now 12 disease-modifying therapies available. Read more about disease-modifying therapies and other treatments for MS and MS symptoms. Other potential therapies in later stages of development for relapsing MS include laquinimod, daclizumab high yield process, and ocrelizumab. Read more about ongoing clinical trials in MS: 

Q. Why aren’t there more treatments for progressive MS?
A. Nearly every therapy approved for relapsing MS has been tested, or is now in testing, in people with progressive forms of the disease, including primary-progressive MS and secondary-progressive MS. Up to now, clinical trials involving people with relapsing MS often rely on counting relapses or doing MRI scans to detect immune activity. The fact that there is no easy way to detect progression quickly is one reason why development of therapies for progressive MS is behind. The National MS Society is investing in better ways to detect benefits of therapies for progressive forms of MS. In addition, the Progressive MS Alliance is a global effort to speed research and treatments on progressive MS. Right now there are large clinical trials going on in progressive MS, including tests of Tysabri,® Gilenya,® Ocrelizumab, Siponimod, and Masitinib. Download a table of trials on focusing on progressive MS (.pdf)

Q. I’ve been hearing news about other new treatments in development for MS. What are some details?
A. Oral and infrequent-dose disease-modifying therapies are just two of many exciting research avenues that address ways to stop MS progression, restore function and end MS forever. Just a few new approaches being explored include adult stem cell transplantation, large-scale clinical trials for progressive MS, trials of agents aimed at protecting or repairing the nervous system, and studies of vitamin D.

Q. Is Lemtrada being tested in progressive MS?
A. Not at this time.

 

Gilenya is a registered trademark of Novartis
Lemtrada is a trademark of Genzyme, a Sanofi Company
Rebif is a registered trademark of EMD Serono and Pfizer
Tysabri is a registered trademark of Biogen Idec and Elan Pharmaceuticals

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

Share